Application 079153

Type: ANDA
Sponsor: TORRENT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	25MG	No	No
002	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	50MG	No	No
003	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	100MG	No	No
004	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A079153-001	TOPIRAMATE	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27
A079153-002	TOPIRAMATE	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27
A079153-003	TOPIRAMATE	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27
A079153-004	TOPIRAMATE	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-001	TOPIRAMATE	25MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-002	TOPIRAMATE	50MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-003	TOPIRAMATE	100MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079153-004	TOPIRAMATE	200MG	TABLET / ORAL	2009-03-27	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079153-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079153-004	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A079153-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A079153-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079153-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A079153-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079153-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079153-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079153-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079153-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079153-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079153-004	AB	1	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	b353e7fb-b976-96d8-e053-2995a90a110a	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57016639-89fe-43ad-89c4-5e7a756dddec	2024-08-14		Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	654f7c48-8c5d-4b97-88d6-397696f82b6a	2024-08-08	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	1ef1c408-30f7-51ee-e063-6394a90ac880	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	e9cb3c29-098c-405f-a200-b436ac7fa1a2	2024-07-24	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals, Inc.	4a656a9f-8eb8-69b7-e054-00144ff8d46c	2024-07-19	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	9ddb8451-a455-87ec-e053-2995a90a5e5e	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	816566bf-b909-606f-e053-2a91aa0ab8c9	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	87dc077b-2c84-522b-e053-2995a90a68bc	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	1a16d6a9-3dd1-ede8-e063-6294a90afe75	2024-06-04	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	78ef4e4e-d391-4417-952b-06202d5000d8	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	10a9e6fa-4d55-6b5c-e063-6294a90a608c	2024-02-05	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	A-S Medication Solutions	93da6674-14dc-4c8d-9424-03e4b2b41479	2023-12-12	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	A-S Medication Solutions	f7f2d1bc-9c65-4798-826f-6902b3ec81dc	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	9a943af0-1c6d-43c2-830a-f303baa16124	2023-11-08		Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57b5d67b-b29b-4c18-a53d-51d5374f3be3	2023-09-28		Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	8bd03bb2-3b9b-4707-a9a4-5618ddc3832f	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	2917ba32-3355-4d64-966a-8518e6fafdbe	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Topiramate generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Proficient Rx LP	80481455-7ad7-4f44-8113-b8b61d8581a0	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: topiramate generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Proficient Rx LP	a30c583a-4b0a-43a6-ae76-19b1a5e916ca	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: TOPIRAMATE generic name: TOPIRAMATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-031	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-032	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-033	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
13668-034	TOPIRAMATE	topiramate	Torrent Pharmaceuticals Limited	ANDA	Current
43063-094	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-094	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-538	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-538	TOPIRAMATE	topiramate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
52959-441	TOPIRAMATE	topiramate	H.J. Harkins Company, Inc.	ANDA	Current
52959-994	TOPIRAMATE	topiramate	H.J. Harkins Company, Inc.	ANDA	Current
61919-185	TOPIRAMATE	topiramate tablet	DIRECT RX	ANDA	Current
61919-825	TOPIRAMATE	TOPIRAMATE	DIRECT RX	ANDA	Current
61919-825	TOPIRAMATE	TOPIRAMATE	DIRECT RX	ANDA	Current
68788-9730	TOPIRAMATE	topiramate	Preferred Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44402	ORIG	2009-04-14
9227	ORIG	2009-04-01